CTRI Number |
CTRI/2025/06/089057 [Registered on: 18/06/2025] Trial Registered Prospectively |
Last Modified On: |
17/06/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
How Neck Muscle Tension Affects Mental Health and Sleep in Working Women with Long-Term Pain? |
Scientific Title of Study
|
Prevalence And Associations Of Neck Muscle EMG Activity On Anxiety, Sleep Quality, And Overall Wellbeing Among Working Women With Chronic Neck Pain : A Cross-sectional Study |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Monika Sharma |
Designation |
Ph.D. Scholar |
Affiliation |
Galgotias University |
Address |
Room No B-316, Department of Physiotherapy, Galgotias University,
Plot No 2, Sector 17A, Opposite Buddha International Circuit,
Yamuna Expy, Greater Noida.
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
Phone |
8859957729 |
Fax |
|
Email |
monika0608sharma@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Monika Sharma |
Designation |
Ph.D. Scholar |
Affiliation |
Galgotias University |
Address |
Room No B-316, Department of Physiotherapy, Galgotias University,
Plot No 2, Sector 17A, Opposite Buddha International Circuit,
Yamuna Expy, Greater Noida.
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
Phone |
8859957729 |
Fax |
|
Email |
monika0608sharma@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mohammad Sidiq |
Designation |
Associate Professor |
Affiliation |
Galgotias University |
Address |
Room No B-319, Department of Physiotherapy, Galgotias University,
Plot No 2, Sector 17A, Opposite Buddha International Circuit,
Yamuna Expy, Greater Noida.
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
Phone |
6006204628 |
Fax |
|
Email |
sidufatima@gmail.com |
|
Source of Monetary or Material Support
|
Research and Development Cell, Galgotias University. |
|
Primary Sponsor
|
Name |
Galgotias University |
Address |
Plot No 2, Sector 17A, Opposite Buddha International Circuit,
Yamuna Expy, Greater Noida, India |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Monika Sharma |
Galgotias University. |
Room no.217 AI block, Galgotias University. Plot No 2, Sector 17A,
Gautam Buddha Nagar, Uttar Pradesh, India Gautam Buddha Nagar UTTAR PRADESH |
08859957729
monika0608sharma@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
School Ethics Committee, SAHS, Galgotias University. |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Female |
Details |
1. Working women for at least one year.
2. Having significant chronic neck pain for more than 3 months.
3. Able to understand English.
4. Willingness to participate and complete the study procedure.
|
|
ExclusionCriteria |
Details |
1. History of medication for any mental, sleep and stress disorder.
2. History of medication or treatment for chronic neck pain.
3. History of anticoagulant medication such as warfarin.
4. Presence of any symptoms of any mental, sleep and stress disorder which required Doctors’ consultation.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. Shimmer3 EMG activity
2. DASS 21
3. Pittsburg Sleep Quality index
4. Perceived Stress |
At Baseline only |
|
Secondary Outcome
|
Outcome |
TimePoints |
WHO Quality of life questionnaire |
At Baseline only |
|
Target Sample Size
|
Total Sample Size="251" Sample Size from India="251"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
04/07/2025 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Chronic neck pain is a prevalent musculoskeletal issue among working women, often leading to significant disruptions in mental health, sleep quality, and overall wellbeing. This cross-sectional study aims to examine the prevalence and associations between neck muscle activity—measured through electromyography (EMG)—and psychological and physiological outcomes such as anxiety, sleep quality, and general wellbeing in this population. Working women aged 25–55 years with chronic neck pain (lasting more than three months) will be recruited. EMG assessments will be used to quantify neck muscle activity during rest and functional tasks. Standardized questionnaires including the Pittsburgh Sleep Quality Index (PSQI), DASS 21, Perceived Stress Test and WHO-5 Wellbeing Index will be administered to evaluate sleep quality, anxiety, stress and wellbeing respectively. The objective is to explore whether abnormal neck muscle EMG activity is significantly associated with increased anxiety, poor sleep, and reduced wellbeing. By identifying these relationships, the study aims to inform integrative clinical strategies that address both physical and psychological dimensions of chronic neck pain in working women. Findings from this research could contribute to targeted interventions that reduce work-related disability and improve the quality of life for affected individuals.
|